Myoglobin Removal by High Cut-off CVVHD (HicoRhabdo)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Gambro Dialysatoren GmbH
Sponsor:
Information provided by (Responsible Party):
Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier:
NCT01467180
First received: November 4, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

A high cut-off dialyzer (septeX) is tested for the removal of myoglobin which is not efficiently removed by standard high flux dialysis membranes. Hypothesis: The high cut-off dialyzer (septeX) can remove 2-fold more efficiently myoglobin from the circulation of Rhabdomyolysis patients as by conventional treatment with standard high flux dialyzer.


Condition Intervention
Rhabdomyolysis
Renal Failure
Device: septeX
Device: HF CVVH

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Myoglobin Reduction by High Cut-off (HCO) Continuous Veno- Venous Hemodialysis (CVVHD) in Patients With Rhabdomyolysis and an Increased Risk for Acute Kidney Injury

Resource links provided by NLM:


Further study details as provided by Gambro Dialysatoren GmbH:

Primary Outcome Measures:
  • Myoglobin plasma level [ Time Frame: 48h ] [ Designated as safety issue: No ]
    Two fold- increased reduction of myoglobin plasma level in favor of the HCO CVVHD group compared with standard therapy group (HF-CVVH and fluid therapy, respectively) after 48 hours treatment time.


Secondary Outcome Measures:
  • eGFR [ Time Frame: at 3 and 6 month after treatment ] [ Designated as safety issue: No ]
    Estimation of kidney function by estimated glomerular filtration rate (eGFR)

  • Duration of hospital stay (days)and Duration of ICU stay (days) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Duration of dialysis dependence (days) [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Diuresis / oliguria (<0.5 ml/kg/12h)/ anuria [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • patient survival [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: November 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCO CVVHD
treatment of rhabdomyolysis pts with septeX dialyzer
Device: septeX
continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h
Active Comparator: HF CVVH
treatment of rhabdomyolysis pts with standard high flux dialyzer
Device: HF CVVH
continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h

Detailed Description:

Excess myoglobin in the circulation is a causative pathogenetic factor of rhabdomyolysis associated with acute kidney injury (AKI). The rapid elimination of myoglobin by standard dialysis membranes is limited to its molecular weight of 17.8kDa, although some removal can be achieved when a convective therapy is applied.

Significant clearance for myoglobin has been reported for high flux membranes from < 8 mL/min (5) up to 22 mL/h (CVVH) (10) and for high cut-off (HCO) membranes a mean clearance rate of 36.2 mL/min in HD mode (7) and 39.2 mL/h in CVVH mode (5). The use of high cut-off (HCO) continuous veno- venous hemodialysis (CVVHD) may constitute a novel therapeutic strategy for effectively reduction of myoglobin in the patient's serum to ameliorate the course of AKI.

Previously, a case study of the removal of myoglobin by HCO-CVVH in one single patient with severe rhabdomyolysis was published.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Rhabdomyolysis
  • placed central venous catheter
  • Indication for RRT due to Serum CK level > 15000 u/L
  • Age ≥ 18 years
  • Signed ICF

Exclusion Criteria:

  • End stage CKD (dialysis dependent) renal failure before manifestation of rhabdomyolysis
  • Pregnancy or lactation
  • Palliative treatment
  • Participation in other clinical studies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467180

Contacts
Contact: Kai Zacharowski, MD + 49 (0) 69/63015998 Direktion.Anaesthesie@kgu.de

Locations
Germany
Klinik für Anästhesiologie, Intensivmedizin, Uni-Klinikum Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Kai Zacharowski, MD    + 49 (0) 69/63015998    Direktion.Anaesthesie@kgu.de   
Principal Investigator: Kai Zacharowski, MD         
Sub-Investigator: Tobias Bingold, MD         
Sub-Investigator: Alexander Koch, MD         
Sub-Investigator: Jens Meier         
Sub-Investigator: Felix Jäger, MD         
Sponsors and Collaborators
Gambro Dialysatoren GmbH
  More Information

No publications provided

Responsible Party: Gambro Dialysatoren GmbH
ClinicalTrials.gov Identifier: NCT01467180     History of Changes
Other Study ID Numbers: 1490, CIV-11-06-000843
Study First Received: November 4, 2011
Last Updated: January 30, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Gambro Dialysatoren GmbH:
septeX
CVVH
CVHD
myoglobin

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Rhabdomyolysis
Kidney Diseases
Urologic Diseases
Muscular Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014